Breo

GUDID 06975488665482

Breo Laser Hair Growth Comb

Shenzhen Breo Technology Co., Ltd.

Hair growth laser device

• Primary Device ID: 06975488665482
• NIH Device Record Key: 68c6ed49-dc73-4775-9b39-6aff33a10821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breo
• Version Model Number: Scalp 3L
• Company DUNS: 529175390
• Company Name: Shenzhen Breo Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975488665482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242620

FDA Product Code

• OAP: Laser, Comb, Hair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-22
• Device Publish Date: 2025-01-14

On-Brand Devices [Breo]

• 06975488664256: N/A
• 06975488665482: Breo Laser Hair Growth Comb